COMMENTARY

AAPM 2010 Expert Video: A Primary Care Perspective

Bill H. McCarberg, MD

Disclosures

February 12, 2010

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My name is Bill McCarberg. I am a primary care doctor with Kaiser Permanente in San Diego. I am also a pain expert, and I'm here at the American Academy of Pain Medicine annual conference in San Antonio. At this conference, there are a variety of topics that are new and unusual and of benefit to a variety of different interests. To me there are certain new topics that I think are particularly interesting because they can help our practice in primary care. These are some of the abuse-deterrent and abuse-resistant products that are making the scene; you're probably going to be seeing some of these in the next year or two.

There's one out already [called] Embeda™, which is a combination of an opioid and an opioid antagonist. The reason why these tamper-resistant and abuse-deterrent products [exist] is because, as you know, a variety of patients that we think are doing just fine on their medication cannot take it the way it was prescribed and get high on it or abuse it.

Let me give you an example. If you take an extended-release oxycodone pill and you chew it or crush it, you get the entire amount in a very short period of time. So instead of having it extended over 24 hours, you now have it over a period of 20 minutes to maybe an hour and a half; that gives somebody a high very quickly, and we know that some of our patients do that.

We know that [in] other patients -- probably the more common abuse scenario -- you write a certain prescription for a hydrocodone product, for example, and you ask the patient to take 2 pills 4 times a day. Instead of [following the instructed dosing] you give them a month's supply and they take the entire amount in the first week. So it's not that they're crushing it or chewing it; they're taking an entire amount over a short period of time, and we don't have any control over it. You think the patient is taking it correctly, but we don't [actually] know how they are taking it; they go 3 weeks [without] any pain control and 1 week where they have too much medication.

So that's the whole idea of these abuse-deterrent, or tamper-resistant, products. They're kind of the same: Tamper-resistant means that you can't chew it or crush it. A variety of companies are coming out with products that have either morphine or oxycodone which, if you try to crush them, or if you dissolve them in liquid or put them in a blender, you can't do it. You have to either break your teeth or destroy the blender before you're able to get it pulverized. Or if you do pulverize it, it doesn't release the compound any quicker, so that's the tamper-resistant quality.

There are [also] a variety of companies coming out with products that -- no matter what you do with them -- you will not have an extended-release product become an immediate-release product. As you can remember, Palladone™, - the extended-release hydromorphone compound that, when [coingested with] alcohol [results in dangerously high drug levels] -- was withdrawn from the market. Well, [pharmaceutical companies are] coming out with new technologies that [prevent that from happening].

The abuse-deterrent formulations are a little different because they have embedded in them something that will make it difficult to tamper with or overuse. For example, [niacin can be put in a pill, which] you already know causes flushing. Let's say instead of taking 2 pills -- [which] doesn't cause any flushing because [there is only a small amount of niacin in 2 pills] -- you take 8 pills all at the same time; now you're getting a large dose of niacin and you'll flush. It will be very adverse and you won't be happy [with the reaction].

Capsaicin [is also being used]; that's that chili powder extract that is very burning. If you put it in a pill it may not cause too much of a problem -- maybe just a little bit -- but if you chew it or crush it or take an overamount of it, it will cause a great deal of burning in your mouth and you won't want to use it. If you pulverize and try to snort it -- as [people] do with some of these medications -- it will [irritate] your mucous membranes. [This is] another method of manufacturing a compound so that it can't be used inappropriately.

The product that's out right now is called Embeda™. It has an opioid in it [as well as] naltrexone -- that's an antagonist drug. Naltrexone is embedded in this pill so that if you take the opioid with the opioid antagonist and you do something to the pill, it will release the antagonist so that the opioid doesn't work anymore. If you crush it or you chew it, it releases the antagonist. It not only inhibits the drug, but if you have an opioid blood level in your system, you will start withdrawing. [This] then gives you an aversive experience.

In reality, most of the time our patients take drugs appropriately. It's just those few patients who take them inappropriately, the people who sell them or do something inappropriately. If we can have a compound that [results in] negative feedback, even people who may want to take it inappropriately will now take it appropriately. I think it gives us a safeguard, a reassurance that what we're doing is the correct thing to do.

I don't want to say that this is for all of our patients, but it certainly allows us to have a little more safeguard.

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